Without evidence of benefit, an intervention should not be presumed to be beneficial or safe.

- Rogue Medic

Paramedic refused to carry dying girl over safety fears

There is a horrible story in the Telegraph on the inquest of a 14 year old girl. Here is the sub-title of the story –

Shannon Powell, a paramedic, refused to carry a dying 14-year-old girl from a cross-country race course because of health and safety fears for herself, a coroner heard.[1]

The biggest problem with the story might be that a paramedic refused to carry a patient, or refused to treat a patient.

The problem is that the story is so badly written that there is no way to tell what really happened. For example –

Shannon Powell is probably not the name of the paramedic. Other parts of the story claim that Shannon Powell is the name of the dead little girl. Which is it? We don’t know. Maybe they are both named Shannon Powell, but that kind of coincidence ought to have been mentioned by the reporter.

The life-saver declined to take part in the “chaotic” rescue mission to save Shannon Powell, saying she was worried about her own back, a witness told the inquest.[1]

That seems bad, but the names have changed. What was “chaotic” about the rescue mission? What kind of back problems does the life-saver have? What is it about this patient – apparently a 14 year old runner, probably not a big patient – that is a danger to the life-saver, that is not a danger on every other call. Won’t most of those calls be for much bigger patients?

Shannon had collapsed in the mud and was foaming at the mouth in a violent fit during a cross-country run but, due to a series of gaffes, life-savers only reached her almost an hour later, the coroner heard.[1]

Was the death of the little girl due to one person, out of many people on scene, not carrying the patient, but not due to a delay in care of almost an hour?

What was the cause of death?

We don’t know, but this is an inquest. One of the purposes of an inquest is to determine the cause of death.

Catherine Sheppard, a marshal, told the hearing that the response was so infuriating she almost attacked the rescue worker.[1]

This is someone who has her priorities so mixed up that she is considering attacking EMS. That would be a felony where I work. A lot of people become infuriated for a lot of reasons. Did Catherine Sheppard (assuming the reporter got the name right) not offer to help? Is it beneath her to help? Was there something unsafe about the scene that prevented the marshal from helping?

“I believe that I walked away at that point. I really was very close to being either verbally or physically abusive to the LAS attendant.[1]

The marshal has responsibility for the children participating in the race, but becomes so upset that she runs away from her responsibilities? Again, this depends on the accuracy of the reporting.

The helper, who is also a history teacher, told how she saw the teenage girl fall wide-eyed and rigid, to the floor.

However, rather than call 999 the assistant said she followed athletics’ club policy and told an organiser who sent a first-aider to the scene.[1]

A child having a possible seizure (a life threatening condition – she did die) and club policy is more important than the health life of the patient?

It was only on their arrival, five minutes later, that she said she called ambulance personnel trained to keep Shannon alive.

However, paramedics only arrived at 12.50pm, almost an hour after Shannon collapsed, she believed.

The inquest in Barnet heard how gates at the park were locked and organisers assumed paramedics would have the keys.[1]

They lock the gates, but assume that the paramedics have the keys.

Is there any good reason not to send someone to the gate to make sure that EMS gets to the right place?

Any reason at all?

Did they send GPS coordinates to the ambulance?

Why think that everyone else knows where you are, just because you know where you are?

There was also confusion about where the park was, which entrance they should use and where the teenager was lying freezing on the muddy track with Mrs Sheppard’s fleece over her, coroner Andrew Walker said.[1]

Mrs. Sheppard would not move the little girl off of the reportedly freezing ground, although she did put her fleece over her. An hour of freezing? Were they trying for therapeutic hypothermia?

Maps of the Middlesex Cross Country Championships’ course contained errors delaying medical help as it was rushed to the scene where the talented youngster collapsed in a fit in Trent Parl, Enfield, north London.[1]

Yet, the headline is about the paramedic refusing to carry the little girl.

Mrs Sheppard told how even as the two paramedics, one male one female, were led up to Shannon by another marshal they walked slowly behind the race assistant.[1]

EMS should never run, unless we are running away from something. Maybe Mrs. Sheppard should have called 999 earlier, if she thought time was important, and should have sent someone to guide EMS to their location, and should have moved the little girl off of the freezing ground. That is assuming that the information has been reported with any accuracy.

“The paramedic at the time was saying ‘we can’t carry her because its health and safety and we might fall over’.

“They didn’t come up with any solution at all. Because of the time we had been there I think I can say this for all of us – we all looked at each other as if to say ‘**** health and safety’.”[1]

That according to first-aider Robbie Proctor. Also –

He said: “One of the stewards made a comment and said ‘how come it took you so long?’

“The comment that came out was ‘this is a low priority call’ or ‘a green call’. That was the male paramedic.”[1]

If the call was dispatched as low priority, maybe that is because the information given to the 999 dispatcher downplayed the seriousness of the little dead girl’s medical condition.

The first-aider described how Shannon was being carried by six people from the course on a trolley bed when she sat bolt upright screaming.[1]

Carrying her required 6 people, but they expected the 2 paramedics to carry her by themselves. Was there more to the condition of the grounds than is being mentioned?

He said: “The last time I put the trolley bed down – and I’m being very honest with the parents here because it haunts me – Shannon sat up and screamed ‘let me go’.”[1]

How many times did these 6 people have to put the trolley bed down and rest? Yet, they expected the 2 paramedics to carry the stretcher?

He told how paramedics believed she was having a fit and gave her the painkiller diazepam when “everything seemed to go haywire.”[1]

Diazepam (Valium) is not a painkiller.

“everything seemed to go haywire.”

Is that supposed to mean that she was given the anti-seizure medicine diazepam because she was having a seizure? Or is it supposed to suggest that giving a seizure patient (fitting patient) anti-seizure medication is inappropriate according to the medical expertise of someone who leaves the patient on the freezing ground for an hour.

The first-aider, who owns the company, Spectrum, brought in to provide medical help at the event, said the paramedics questioned his qualifications and began asking bystanders if they knew how to provide lifesaving CPR.[1]

The owner of the company that was contracted to provide the wonderful medical care (as reported in the article) to the dead girl is trying to put the blame on someone else.

The race marshal appears to be doing the same thing.

Am I a bit jaded in doubting their objectivity?

Shannon was taken from Chase Farm Hospital, in Enfield, where she died of sudden death syndrome on January 18, this year.[1]

Was any CPR indicated at any time on scene or were the paramedics just giving Mr. Proctor a hard time? It is impossible to tell from the story.

The article finishes with –

The inquest continues.[1]

I would love to see the full transcript of the inquest. This is so badly reported that I have no idea how much of what is written in the article is true. The reporter does not appear to have a clue about how to report a story.

Footnotes:

[1] Paramedic refused to carry dying girl over safety fears
Telegraph
1:50PM GMT 08 Dec 2011
Article

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Bad Shock – Automated Devices for Jolting Hearts May Save Fewer Lives in Hospitals


Image credit.

Do AEDs (Automated External Defibrillators) save lives?

Yes, but . . .

Just over a decade ago, hospitals around the country began spending millions of dollars to buy automated defibrillators to save the lives of more patients who go into sudden cardiac arrest. The purchases were spurred by a recommendation from an American Heart Association committee that decided the new equipment would bring patients speedier emergency help.[1]

and

A FairWarning review of the decision that prompted the switch reveals that the pivotal committee recommendation was made without clinical research answering a crucial question: Did the new devices, when used in hospitals, produce better results than the old equipment?

Instead, committee members endorsed automated defibrillators largely on the unproven theory that they would improve response times because even less-skilled hospital staffers could operate them.[1]

This is the beginning of an article that makes some valid points, but ends up concluding that this apparent mistake was due to financial bias.

I think that this conclusion by the author is based on an ideological bias of the author.

Did the AHA (American Heart Association) make inappropriate recommendations without any research?


Image credit.[2]

Class IIa?

Class IIa
Benefit >> Risk
It is reasonable to perform procedure/administer treatment or perform diagnostic test/ assessment.[3]

What about research to support this claim?

Extraordinary survival rates—as high as 49%—have been reported in PAD programs.17 18 19 20 21 22 23 24 These rates are twice those previously reported for the most effective EMS systems.25 [4]

But that is not in hospitals.

AEDs are also used by healthcare professionals in ambulances, hospitals, dental clinics, and physicians’ offices.29 30 31 32 33 34 [4]

While most of those are discussions of the concept of in hospital AED use, there is also research.

Should there have been more research?

That is an important question. I think that the AHA (and ILCOR – International Liaison Committee on Resuscitation) are too quick to implement new treatments. A big problem is that the treatments become Standards Of Care and are difficult to remove from guidelines once enshrined there.

I have stated before that these recommendations need to come with an expiration date, after which they are removed from the guidelines, unless there is strong evidence to support their efficacy.

Does that mean that I think those encouraging the rapid implementation of unproven, or not well studied treatments, are corrupt?

No.

Those who are prone to conspiracy theories seem to see corruption everywhere in everyone else. And it is often just about money. People seem to be much more willing to break laws for ideology, than for money. Money is the simple answer for those who do not want to have to understand.

Maybe I am reading too much into this. Maybe FairWarning really is fair or objective.

Earlier this year, FairWarning did a report claiming that a report by a bunch of lawyers raises important questions about vaccines and autism.[5]

No, I am not reading too much into their actions. FairWarning makes a home for at least one full blown conspiracy theorists. Here is a little bit about the lawyers behind this research.

They are Mary Holland, a lawyer who wrote the chapter defending Andrew Wakefield in the recent book Vaccine Epidemic; Louis Conte, the father of two boys he believes are vaccine injured and the former director of something called the “Vaccine Injury Compensation Program Justice Project”; Robert Krakow, who is an attorney who represents clients who have filed Vaccine Court claims and who has filed his own claim on behalf of his son; and Lisa Colin, one of Krakow’s colleagues.[6]

The lawyer-study is reviewed by a real scientist at Science-Based Medicine.[7] When will the scientifically naive stop falling for the fraud of a vaccine/autism connection?


Image credit.

Antivaccinationists and research are a ridiculous combination. Did Lilly Fowler write about vaccines and autism? No, but she did write about cell phones and cancer as if she thinks she understands the research. Giving press to a bunch of lawyers pushing a profitable conspiracy theory demonstrates that FairWarning‘s editors do not have any integrity. Nor do they have any understanding of medical research, so how much confidence should we have in their reporters?

The only fair warning about this organization is to avoid their reliance on stereotypes. Stereotypes are just the breeding ground for conspiracy theories.

They also have their donate button all over the place so that the more susceptible to snake oil can be separated from their money more easily.

I will write about what the the actual study, Automated external defibrillators and survival after in-hospital cardiac arrest,[8] found next week. Thank you to Greg Friese of Everyday EMS Tips, EMS EduCast, and Medical Author Chat for sending me the article.

Footnotes:

[1] Bad Shock: Automated Devices for Jolting Hearts May Save Fewer Lives in Hospitals
By Lilly Fowler
November 14, 2011
Fair Warning
Article

[2] Part 4: The Automated External Defibrillator : Key Link in the Chain of Survival
2000 AHA Guidelines
Circulation. 2000;102:I-60-I-76, doi:10.1161/01.CIR.102.suppl_1.I-60
Free Full Text from Circulation with links to Free PDF Download

[3] Ethics, Research, and IRBs
Rogue Medic
Part II
Part II

[4] Part 4: The Automated External Defibrillator : Key Link in the Chain of Survival
2000 AHA Guidelines
Circulation. 2000;102:I-60-I-76, doi:10.1161/01.CIR.102.suppl_1.I-60
Free Full Text from Circulation with links to Free PDF Download

[5] Analysis Finds Evidence of Autism in Many Vaccine Injury Cases
By Laurie Udesky
May 10, 2011
FairWarning
Report

[6] And the winner is…Fox News
By Seth Mnookin
Posted: May 10, 2011
The Panic Virus
Article

[7] When you can’t win on science, invoke the law…
Science-Based Medicine
Article

[8] Automated external defibrillators and survival after in-hospital cardiac arrest.
Chan PS, Krumholz HM, Spertus JA, Jones PG, Cram P, Berg RA, Peberdy MA, Nadkarni V, Mancini ME, Nallamothu BK; American Heart Association National Registry of Cardiopulmonary Resuscitation (NRCPR) Investigators.
JAMA. 2010 Nov 17;304(19):2129-36. Epub 2010 Nov 15.
PMID: 21078809 [PubMed – indexed for MEDLINE]

Free Full Text from JAMA with links to Full Text PDF Download

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The Fraud of “If It Saves Just One Life It’s Worth It”

We have many people who claim that it is acceptable to do certain things with the excuse that – If It Saves Just One Life It’s Worth It.

Perhaps the best way to save lives is to kill anyone who uses this justification.

Will it save any lives?

We are supposed to stop considering risks and benefits. We are supposed to be afraid of being viewed as callous with the lives of others.

The reality is that whatever is being considered is probably going to kill more people than it will ever save – that is why they use scare tactics. If there were good reasons for what they want, they would not need scare tactics.

If It Saves Just One Life It’s Worth It.

Saving lives is good.

It’s For The Children.

Helping children is good.

The drug has a Black Box Warning! We can’t use that dangerous drug!

Black box warnings do point out possible problems with giving a medication.

All medications have side effects. Some of these side effects can result in death. Medications with lethal side effects include water and oxygen. These are medication, even though we use them every day without prescriptions. Too much oxygen can kill. Too much water can kill. Clearly, we need to protect people from these dangerous chemicals.

We need to prohibit exposure to water. We need to prohibit exposure to oxygen. If It Saves Just One Life It’s Worth It.

Would we save any lives? Of course not, but this isn’t about reality. This is about creating the appearance that opponents of whatever poorly considered idea are reckless and dangerous.

If It Saves Just One Life It’s Worth It means that the person does not know what he is discussing and that he does not want to know. Unintended consequences do not matter. Scare tactics are all that matter.


Image credit.
The unbalanced perspective of If It Saves Just One Life It’s Worth It in a picture.

Should this one theoretical life saved be more important than all of the damage done to everyone else?

Why do so few people consider that unintended consequences affect everything?

If this post can save even one person from falling for the fraud of If It Saves Just One Life It’s Worth It, then this post was worth it. 😉

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Airplanes, Streisand, and Patient Safety

Addressing the topic of treatment errors, at EMS Patient Perspective Bob Sullivan writes about ways to deal with our inevitable errors. It isn’t just the errors of others that we should be considering. Our errors are inevitable, too. As many people have pointed out, anybody who claims to be free of errors is incredibly inexperienced, is incredibly naive, or is telling a lie. Maybe all three.

I know what some of you are thinking –

But if we don’t severely punish errors, we are encouraging errors!

This is nonsense.

This just results in people covering up their errors. Everyone makes errors, so 100% error free is impossible. Even the Six Sigma claim of only 3.4 errors per million plus actions is hopelessly optimistic.[1]

A lot depends on what we classify as an error. We make mistakes every day. Maybe we should change the name of our species from Homo sapiens (wise man) to the more accurate Homo errant (mistaken man) or Homo fraudulenti (deceitful man).

We make mistakes, but to create the impression of perfection, we aggressively punish the mistakes of others and we even more aggressively cover up our own mistakes. This is unethical and dishonest, but it is likely to produce far more mistakes than any less punitive system for dealing with errors.

Considering the possibility of filming all of our actions in EMS, Bob writes –

So imagine what non-punitive, collaborative reviews of patient care in the back of an ambulance could do. I would gladly narrate a video of the cardiac arrest I got in trouble for to explain what I was thinking at each step, where we got off track, and how that error could be prevented in the future. If this was widely practiced, how many other mistakes could be avoided? How much better would our care be?[2]

non-punitive?

But we must have the ritual sacrifice of the person who is not politically well connected. How else can we convince those, who are ignorant of what we really do, that we know what we are doing?

If we do not punish errors, we feel inadequate.

Consider just how pathetic that is.

We would rather punish errors than educate. Punishment is not education. Punishment is how we deal with our failure to educate or our failure to supervise. Punishment teaches others that we are incompetent at education.

Errors are unintentional. Punishment is only appropriate for things that are intentional. The distinction is important.

collaborative?

Having everyone work at improving quality, rather than the methods of Stalin and Hitler of having informants report the mistakes of others and also punishing those who do not report every mistake?

That would require maturity. We only fake it when it comes to maturity.

If this sounds intimidating at first, it should. It would require our profession to grow up. We would take responsibility for the care we give and the care given by the people we certify.[2]

EMS grow up?

That is an idea that deserves to be punished./

For even suggesting it we should punish Bob Sullivan. What other evil ideas will he come up with at EMS Patient Perspective?

Footnotes:

[1] Six Sigma
Wikipedia
Article

A six sigma process is one in which 99.99966% of the products manufactured are statistically expected to be free of defects (3.4 defects per million).

[2] Airplanes, Streisand, and Patient Safety
EMS Patient Perspective
Article

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Unintended Consequence, Banks, and Regulation

Debit card fees: Why Bank of America will charge $5 for debit card use

In early 2012, Bank of America customers with basic accounts will be charged a $5 monthly fee for shopping with their debit cards. The fee will be charged whether customers choose ‘debit’ or ‘credit’ at the point of sale.

Sen. Dick Durbin (D) of Illinois wrote an amendment to the Dodd-Frank make finance all better bill. He is limiting the money that can be charged by banks on individual purchases. The banks have responded exactly as any sensible person would expect them to.

Sen. Durbin, apparently not being a sensible person, just a member of Congress, claims to be shocked at this example of unintended consequence. Why didn’t he think about what the response would be?

An Associated Press-GfK poll found that if debit card users incurred a $5 fee, 66 percent said they would simply change their payment method.

Change their payment method?

CA$H.

What will be the unintended consequence of that?

Lower sales tax revenues, lower business tax revenues.

Sen. Durbin has just passed a business tax cut and he did not even realize it.

Of course, this only applies to those business that do not report all of their cash income. We know there are some that do this. We can expect that as the income in cash increases, these businesses will not start reporting a higher percentage of their cash business.

Sen. Durbin apparently writes regulations as if he is tailgating in the fast lane. He cannot imagine that there will be any reason for the vehicle in front of him to suddenly brake, or for the vehicle in front of that vehicle to suddenly break. Why plan ahead, when he can just use his position to rant and rave about how others abuse their position of power. As if he is not just as guilty.

.

If We Were Really Serious About Intubation Quality

If We Were Really Serious About Intubation Quality – we would require that each medic be intubated by a different medic at least once a month.

This would get rid of all of the whining about a lack of opportunity to get any live practice.

We would quickly learn who can intubate.

Medics would develop an interest in outcomes that are longer term than just dropping a body off at the ED (Emergency Department).

 

Each month every medic gets at least one tube – or no tubes.

 

Every month.

We get to listen to some Ludwig van while letting our droogies show their stuff.

If you cannot convince any medic to let you attempt to intubate them, then you are prohibited from attempting to intubate any patient for any reason. This will quickly lead to more accurate peer assessment of quality.

You cannot attempt to intubate the same medic in the same year, unless there are fewer than 13 medics in your organization. This means that you can’t just end up with the easiest tube each month.

You cannot have the same medic attempt to intubate you in the same year, unless there are fewer than 13 medics in your organization.

You must also be on the receiving end of an intubation attempt or you are prohibited from attempting to intubate any patient for any reason.

If you cannot convince any of your fellow medics to allow you to attempt to intubate them, do we need to know anything more about how pathetic you are at intubation?

If no medic will allow you to attempt to intubate them, is there any good reason to allow you to harm patients by attempting to intubate the patients?

But . . but . . . but . . . what about infection?

Is there any better way to teach sterile technique?

But . . but . . . but . . . what about irritation?

Is there a better way to get medics to realize that we should lubricate the tube?

But . . but . . . but . . . what about injury?

Is there any better way to teach that intubation is supposed to be gentle?

But . . but . . . but . . . what about . . . ?

What about growing a set and learning to manage an airway?

We also need to make sure that our coworkers know how to manage an airway.

If the complication rate is too high when paramedics attempt to intubate other healthy paramedics in a controlled setting, why should we permit paramedics to attempt to intubate sick people in uncontrolled settings?

Most important may be the last part – you will be hooked up to a vent for 10 minutes after being moved from one stretcher to another.

And you will be heavily sedated, so you will not be assisting the tube into the right place, and you will not be able to let anyone know if your CO2 level is climbing rapidly due to a misplaced/dislodged tube.

Unreasonable?

No.

What is unreasonable is the pathetic way we assess the quality of airway management in EMS.

Do you really trust the intubation skills of your coworkers?

Are you willing to prove it?

Every month.

We would rather whine about how it is unfair to take away intubation.

We do not deserve to intubate.

Our patients do not deserve to be abused by us.

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Dietary Supplements—Regulatory Issues and Implications for Public Health

A couple of days ago I wrote about the misleading decision from the Supreme Court on the use of the DSHEA (Dietary Supplement Health and Education Act[1]) to scam people and to harm them.[2] It is interesting that on the same day there was an article about DSHEA published in JAMA (the Journal of the American Medical Association). Here is some information from the article.

In 2009, a US Government Accountability Office (GAO) report found that “consumers are not well-informed about the safety and efficacy of dietary supplements and have difficulty interpreting the labels on these products.”2 In fact, one of the most significant problems with DSHEA is that it allows structure and function claims to appear on product labels; as long as products do not claim to treat, prevent, or cure specific diseases, they can enter and remain in the marketplace.1​[3]

In other words, DSHEA encourages doubletalk, misdirection, and lies.

How could these drug manufacturers supplement manufacturers know that their drugs supplements would be marketed as safe and effective, even though there is no good evidence to support their claims?

How could anyone expect that these drug manufacturers supplement manufacturers would lie about their products to make money?

After all, these are just supplements – pure and good and natural – right?

In preparing its 2010 report, the GAO investigated 22 retailers of herbal dietary supplements, hiring an accredited laboratory to examine 40 single-ingredient supplements for the presence of lead, arsenic, mercury, cadmium, and assorted pesticides.3​ Although none of the supplements qualified as having an acute toxicity hazard, trace amounts of at least 1 contaminant were found in 37 of 40 products.3[3]

Nothing says safe like unknown amounts of mercury.

Nothing says safe like unknown amounts of lead.

Nothing says safe like unknown amounts of radioactive cadmium.

Nothing says safe like unknown amounts of arsenic.

Nothing says safe like unknown amounts of assorted pesticides.

If you only take small amounts of these contaminated products, you should be safe. If you take more, you are just taking more contaminant.

37/40 products contaminated.

Safe?

92.5% contaminated.

Healthy?

These supplement pushers get a grade of A in hiding toxic contaminants in their health products. Except they claim that their product are safe alternatives to real medicine. 😳

Footnotes:

[1] How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA
by Stephen Barrett, M.D.
QuackWatch
Article

[2] Access to Safety Data — Stockholders versus Prescribers and Missing the Point
Rogue Medic
Article

[3] Dietary Supplements–Regulatory Issues and Implications for Public Health.
Denham BE.
JAMA. 2011 Jul 5. [Epub ahead of print] No abstract available.
PMID: 21730229 [PubMed – as supplied by publisher]

Free Full Text from JAMA with Links to Full Text PDF Download

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Access to Safety Data — Stockholders versus Prescribers and Missing the Point

The Supreme Court recently decided, in Matrixx Initiatives, Inc. v. Siracusano, that –

Plain English Holding: A drug company’s failure to make public reports of adverse drug reactions can constitute securities fraud, even if the number of adverse reactions is not statistically significant.

Judgment: Affirmed., 9-0, in an opinion by Justice Sotomayor on March 22, 2011.[1]

The legal and medical systems both strive for truth while acknowledging that there are no absolutes. Both systems require evidence, which they categorize in a hierarchy of levels, on which to base decisions that can have major effects on the quality and even quantity of people’s lives.[2]

The major theme of the brief is predictability and certainty: pharmaceutical companies get thousands (if not tens of thousands) of reports each year of possible adverse incidents related to their pharmaceuticals.[3]

Everybody seems to be looking at this case from just one perspective.

The perspective of what is already known about side effects.

The perspective of what can be proven about side effects.

The perspective of “will there ever be enough reports to reach statistical significance” about side effects?

We do not know.

We do know that if there are other cases, once these reports start getting publicity, more of these cases will be reported. The lack of statistical significance in what is already known is not what is important. The statistical significance of the total number of cases of loss of smell is much more important.

This is something Matrixx Initiatives does not know, but wants to hide from the public. Fortunately, the Supreme Court did not fall for this.

This whole case ignores the more important fraud.

Zicam is sold as a supplement.

Matrixx claims that Zicam is not a drug.

This is just one of the problems of the bigger fraud that is alternative medicine.

The quacks sell homeopathic remedies claiming that there is nothing left in them, so the nothings definitely can’t harm anyone. What could be safer than nothing?

But there clearly is a lot of something in some of these nothings.

Most alternative medicine just relies on selling the placebo effect. However, some companies will put real medicine in products so that the patient victim will feel something real.

The DSHEA (Dietary Supplement Health and Education Act of 1994)[4] essentially prevents the FDA (Food and Drug Administration) from regulating “dietary supplements.” DSHEA permits manufacturers to make bogus “health” claims for them, as long as there is plausible deniability about how medical the claim is.

Eventually, the FDA had to do something.

These claims make these products drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals.[5]

But . . .

 

I’ve seen it work![6] 

I get a cold.

I rest and I drink fluids.

I get better in a week.

Or –

I get a cold.

I take a remedy and I rest and I drink fluids.

I get better in 7 days.

But at least I feel like I am doing something!

What is the something that I am doing?

 

I am being ripped off.

 

Sorting the wheat of true adverse drug effects from the chaff of biologic variability and chance associations is exceedingly difficult.[2]

Recognizing the lack of effect of alternative medicine is so difficult that we give billions of dollars to these frauds every year.

The really sad thing is that a lot of what we do in EMS is not any better. We are selling wishful thinking at outrageous prices and with real side effects.

Trendelenburg position, spinal immobilization, helicopters for mechanism of injury, epinephrine for cardiac arrest, amiodarone for cardiac arrest, lidocaine for cardiac arrest, and so on through a lot of what is in our drug bags.

Footnotes:

[1] Matrixx Initiatives, Inc. v. Siracusano
SCOTUSblog
Main page with links to more than you want to know about the case.

[2] Access to Safety Data – Stockholders versus Prescribers.
Pfeffer MA, Bowler MB.
N Engl J Med. 2011 Jun 29. [Epub ahead of print]
PMID: 21714642 [PubMed – as supplied by publisher]

Free Full Text with link to Free PDF Download from N Engl J Med.

[3] Opinion analysis: Chalk one up for the Ninth Circuit
On Tuesday, the Court issued its decision in Matrixx Initiatives, Inc. v. Siracusano (09-1156).

Ronald Mann, Contributor
Posted Thursday, March 24th, 2011 7:10 am
SCOTUSblog
Article

[4] How the Dietary Supplement Health and Education Act of 1994 Weakened the FDA
by Stephen Barrett, M.D.
QuackWatch
Article

[5] Matrixx Initiatives, Inc. AKA Zicam LLC 6/16/09
WARNING LETTER

FDA
Warning Letter

[6] I’ve Seen It Work and Other Lies
Rogue Medic
Article

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